Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards (ATBREFSURMED)
|ClinicalTrials.gov Identifier: NCT01136200|
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : July 29, 2014
CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.
OBJECTIVES: To show using a randomized trial that patients with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.
METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients:
- Control group: antibiotic prescriptions will be initiated and managed by the attending physicians
- Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.
STUDY PROCESS: The study will took place in 4 university hospitals. Two medical or surgical wards will participate by hospital. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.
|Condition or disease||Intervention/treatment||Phase|
|Patients Receiving Antimicrobial Therapy||Other: Infectious disease specialist advice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Infectious disease specialist advice
Patients receiving the intervention (infectious disease specialist advice)
Other: Infectious disease specialist advice
Indication, choice, dosing and duration of antimicrobial therapy
No Intervention: Control
Patients not receiving infectious disease specialist advice
- Appropriateness of antimicrobial therapy [ Time Frame: Between days 7 and 10 after starting antimicrobial therapy ]Appropriateness of antimicrobial therapy will be evaluated at the start, between days 3 and 5, and at the end of therapy (between days 7 and 10).
- Clinical impact [ Time Frame: Between days 7 and 10 after starting antimicrobial therapy ]Length of hospitalization;clinical outcome: resolution of infection; in hospital mortality
- Antibiotic exposure [ Time Frame: 14 days ]
Antibiotic exposure will be evaluated using the following parameters:
number of days of therapy/numbers of days of hospitalization; defined daily doses of antibiotic/number of days of hospitalization
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136200
|Henri Mondor University Hospital|
|Créteil, France, 94010|
|Principal Investigator:||Philippe Lesprit, MD||Assistance Publique - Hôpitaux de Paris|